Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today provided additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect® microneedle delivery of D-MNA and P-MNA for basal cell carcinoma (BCC).
The dataset demonstrated 73% clinical clearance and 40% histological clearance in the 200-µg treatment cohort at Day 57, representing the strongest treatment response observed in the study.
We believe that these findings are particularly notable given the device-based mechanism of SkinJect, where microneedle delivery itself may produce biological activity that can contribute to responses observed even in placebo active arm (P-MNA), that was not tip-loaded with the chemotherapeutic agent.
Active placebo arms are not uncommon in device-drug combination trials and can be an acceptable regulatory data point.
The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma.
The Company believes the dataset represents decision-grade evidence supporting advancement of the SkinJect program toward regulatory discussions and potential strategic partnerships.
Interpreting Clinical and Histological Endpoints
The SKNJCT-003 study evaluated two complementary efficacy endpoints:
Clinical clearance – visual disappearance of the treated lesion
Histological clearance – absence of tumor cells on excisional biopsy
The 200-µg treatment cohort demonstrated the strongest efficacy signal, achieving 73% clinical clearance and 40%histological clearance at Day 57. Taken together, the results suggest that a meaningful proportion of treated lesions achieved both visual and histological clearance, supporting the therapeutic potential of the SkinJect platform.
Interpreting Biological Activity in the Placebo Active Arm (P-MNA) Cohort:
The biological activity observed in the P-MNA is consistent with mechanisms well recognized in intratumoral device therapies and microneedle-based delivery systems, and is consistent with what the company had observed in the SKNJCT-001 Phase 1 safety and tolerability study in March of 2021, and the positively trending interim analysis of SKNJCT-003 in March of 2023 which demonstrated more than sixty (60) percent of clinical clearance.
Microneedle insertion into tumor tissue produces localized micro-injury that can trigger and amplify several biological processes, including:
mechanical disruption of tumor architecture
activation of wound-healing pathways
localized immune signaling
Basal cell carcinoma is known to be a highly immunogenic tumor, and these localized biological responses can contribute to tumor regression even in the absence of an active therapeutic agent.
These mechanisms have been described in dermatologic oncology literature and reflect the inherent biological activity of microneedle-based delivery platforms.
Microneedle-based tumor disruption is increasingly recognized as a biologically active delivery platform, and thetherapeutic contribution of the active drug should be interpreted on top of this device-mediated biological effect.
Importantly, the study demonstrated clear separation between the P-MNA cohort and the 200-µg treatment cohort at Day 57, where the active treatment group achieved 73% clinical clearance compared with 38% in P-MNA, supporting the additional therapeutic contribution of the drug delivered through the SkinJect microneedle system.
The Company believes that the dataset should be interpreted in the context of both:
- Biologic activity from the microneedle delivery platform
- Additional drug-related therapeutic effect
Potential Clinical Impact
Basal cell carcinoma is the most common cancer worldwide, with millions of lesions treated each year.
The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of fourtreated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.
In clinical practice, lesions that achieve visual clearance are often monitored through routine dermatologic follow-up,reserving surgical procedures for lesions that recur or persist.
If confirmed in future studies, this approach could provide dermatologists with a minimally invasive treatment option that may reduce the need for Mohs surgery, the current surgical standard for many basal cell carcinomas.
The treatment approach may be particularly relevant for patients with Gorlin Syndrome, a rare genetic condition in whichindividuals may develop dozens or hundreds of basal cell carcinomas throughout their lifetime. For these patients, repeated surgical procedures can be extremely burdensome, impractical and potentially disfiguring; a non-invasivetreatment could be transformative.
Dataset Supports Next Development Milestones
Based on the available data, the Company considers the current dataset to be decision-grade and supportive of the next phase of development. The Company intends to use these results to advance regulatory discussions with the Food and Drug Administration (the “FDA”) and to accelerate partnering discussions, as further elaborated on below.
Advance regulatory discussions with the FDA
The Company plans to proceed toward an End-of-Phase-2 meeting with the FDA to determine the optimal registrational development pathway, where the clinical development strategy may include:
continued evaluation of the 200-µg dose
potential optimization of patch application duration
evaluation of additional treatment sessions
potential refinement of treatment intervals
Accelerate partnering discussions
The dataset also provides a foundation for ongoing discussions with potential strategic partners, particularly companies active in dermatology and oncology.
Management Commentary
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, commented:
“We believe the SKNJCT-003 dataset reinforces the premise of SkinJect as a potential new treatment modality for basal cell carcinoma. The separation observed in the 200-µg treatment cohort, combined with the known biological activity of microneedle-based delivery systems, provides a strong foundation for advancing the program toward regulatory discussions and potential strategic partnerships.
The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.”
Strategic Focus on Phase 2 De-Risking and Partnering
Medicus’ development strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization.
The Company continues to assemble decision-grade clinical and regulatory data packages across its portfolio to support this partnering-focused model.